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Class 2 Device Recall Triton Infusion Pump |
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Date Initiated by Firm |
October 01, 2015 |
Date Posted |
November 06, 2015 |
Recall Status1 |
Terminated 3 on July 12, 2016 |
Recall Number |
Z-0242-2016 |
Recall Event ID |
72331 |
510(K)Number |
K070529
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Product Classification |
Pump, infusion - Product Code FRN
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Product |
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
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Code Information |
Model numbers 300000, 400000 |
Recalling Firm/ Manufacturer |
WalkMed Infusion, LLC 6555 S Kenton St Ste 304 Englewood CO 80111-6838
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For Additional Information Contact |
303-420-9569
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Manufacturer Reason for Recall |
The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the actual bag volume.
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FDA Determined Cause 2 |
Device Design |
Action |
A Field Notification (letter) was provided to users on 10/01/15 to remind them of the following:use air elimination filters, as appropriate, not to over program into the device the volume to be infused, remove air from the IV bag prior to starting the infusion, issues associated with the use of Venofer or similar drugs. No products are being returned. |
Quantity in Commerce |
4695 units |
Distribution |
Distributed in the states of AL, CA, CO, DE, FL, GA, IL, MA, MD, MI, MN, MS, NC, NJ, NM, NV, NY, OH, PA, TN, TX, and WA. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FRN and Original Applicant = DEFINITIVE MEDICAL TECHNOLOGIES, LTD.
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